On November 19, 2024, the Therapeutic Goods Administration (TGA) of Australia issued an urgent safety alert regarding Phenergan, a medication containing promethazine, advising against its use in children under six years old.

This alert follows the TGA's documentation of 235 cases of severe side effects linked to promethazine, including 77 reported deaths, one of which involved a child under six.

Concerns about promethazine stem from serious side effects, such as hyperactivity, aggression, hallucinations, and potentially fatal respiratory issues.

High doses of Phenergan may lead to cognitive difficulties and potential reversible intellectual disabilities in children under six.

As a first-generation antihistamine, promethazine is known to cross the blood-brain barrier, which can significantly affect brain chemistry and lead to sedation.

Parents are encouraged to consider safer alternatives for treating allergies in young children, such as non-sedating antihistamines like Claratyne (loratadine) and Zyrtec (cetirizine).

Health professionals have been advised to inform parents and caregivers about the risks associated with administering Phenergan to children under six, although updated labels may take time to appear in pharmacies.

The TGA's investigation revealed that Phenergan could cause psychiatric and central nervous system side effects in young children, necessitating the updated warnings.

Phenergan is commonly used to treat hay fever, nausea, allergies, and for short-term sedation, but its risks in young children are becoming increasingly clear.

The updated warnings will be reflected in the Product Information (PI) and Consumer Medicine Information (CMI) documents for Phenergan and other oral promethazine products.

In case of concerning side effects from promethazine or any other medication, parents should contact the Poisons Information Centre in Australia or call emergency services.

Parents are also advised to properly dispose of any unused promethazine products by returning them to a pharmacy to protect the environment.